Trial Involving Subjects Over 70 Years of Age With Non Small-cell Lung Cancer of Stage IV and Comparing a "Classical" Strategy of Treatment Allocation, With an"Optimized" Strategy Allocating the Same Treatments

Last updated: March 30, 2023
Sponsor: Rennes University Hospital
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01257139
EudraCT 2008-008372-13
  • Ages > 70
  • All Genders

Study Summary

This is a phase III randomized multicenter study involving subjects over 70 years of age with non small-cell lung cancer of IV and a PS of 0, 1 or 2, who have not previously received chemotherapy. The aim is to validate the use of a simplified geriatric scale (SGS) as a screening tool. If the SGS results are normal, the patient will be treated with dual-agent therapy based on platinum (carboplatin + pemetrexed if the histology is non epidermoid, carboplatin + gemcitabin if the histology is epidermoid), with no further geriatric assessment. When the SGS reveals abnormalities, a comprehensive geriatric evaluation (CGE) will be used to define two subpopulations on Balducci's fragility scale, who will receive either monotherapy (docetaxel) or best supportive care.

The strategy based on the SGS will be compared with a treatment algorithm based on standard criteria (PS and age), with no specific geriatric assessment. The main endpoint is the time to treatment failure. The SGS is composed of the Charlson co-morbidity scale, functional assessment based on PS, Katz' ADL scale, Lawton's simplified IADL scale, simplified cognitive assessment with the mini-MMSE according to Schultz-Larsen, a geriatric depression scale (GDS 5), and screening for a geriatric syndrome defined by the existence of dementia, repeated falls, and urinary and fecal incontinence. The SGS will be validated by comparison with the CGE, that will be administered systematically at enrollment. All the SGS items are included in the CGE.

Secondary endpoints will be quality of life (measured with the LCSS and EuroQoL questionnaires), overall survival, the objective response rate, and toxicity. The investigators will also study the predictive power of nutritional indices such as the PINI and the Buzby score with respect to survival, the treatment response, and tolerability.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cytologically or histologically proven NSCLC(adenocarcinoma, epidermoid carcinoma,large-cell carcinoma) of stage IV with histologically or cytologically proven pleurisyor neoplastic pericarditis.
  • No previous systemic chemotherapy for lung cancer.
  • Presence of at least one measurable target lesion (RECIST rules) in a non irradiatedregion.
  • Age strictly at least 70 years.
  • PS 0, 1 or 2.
  • Life expectancy sup 12 weeks.
  • Creatinine clearance at least 45 ml per min with MDRD Formula (Modification in theDiet in Renal Disease).
  • Normal hematologic function: absolute polymorphonuclear neutrophil count > 1.5 . 109per l and or platelets sup 100 . 109/l, hemoglobin sup 9.5 g per dl
  • Normal hepatic function: bilirubin inf 1.5 x normal, SGOT and SGPT inf 2.5 . normal.
  • Patients with metastatic relapse (cytologically or histologically proven) of primarylung cancer in a non irradiated region, after surgical excision or local externalradiotherapy.
  • Prior irradiation is authorized if it involved less than 25 percent of the total bonemarrow volume.
  • Men must be surgically sterile or must accept the use of an effective contraceptivemethodall along and until 6 months after the treatment period
  • Signed written informed consent.

Exclusion

Exclusion Criteria:

  • Other severe concurrent disorders that occurred during the prior six months beforeenrollment (myocardial infection, severe or unstable angor, coronarian or periphericarterial bypass operation, NYHA class 3 or 4 congestive heart failure, transient orconstituted cerebral ischemic attack, at least grade 2 peripheral neuropathy, stomachulcer, erosive oesophagitis or gastritis, psychiatric or neurological disorderspreventing the patient from understanding the trial, uncontrolled infections).
  • Another previous or concomitant cancer, except for basocellular cancer of the skin ortreated cervical cancer in situ, or appropriately treated localized lowgrade prostatecancer (Gleason score inf 6), unless the initial tumor was diagnosed and definitivelytreated more than 5 years previously, with no evidence of relapse.
  • Bronchoalveolar or neuroendocrine or composite cancers
  • Superior caval syndrome.
  • Presence of symptomatic brain metastases.
  • Peripheral neuropathies (grade sup 2).
  • Performance status sup 2 (ECOG).
  • A significant third liquid part (for example ascitis or pleural effusion) hat can't becontrolled with drainage or other procedures before enrollment
  • Impossibility to stop a treatment by aspirin (if the dose is more than 1.3 mg per day)or NSAI during 5 days (8 days for molecules with long period action like piroxicam
  • Concurrent participation in another clinical trial.
  • Definitive contraindication to steroids or folic acid and vitamin B12 if histology isnon-epidermoid.
  • All concurrent radiotherapy, except for local palliative bone radiotherapy.
  • Concurrent administration of one or several other antitumor therapies. Recentvaccination for yellow fever (during the 30 days before enrollment)
  • Psychological, familial, social or geographic difficulties preventing follow-up asdefined by the protocol.
  • Administrative or legal detention.
  • Contraindication to the study drugs.
  • Concurrent participation in another clinical trial

Study Design

Total Participants: 490
Study Start date:
January 01, 2010
Estimated Completion Date:
July 31, 2014

Connect with a study center

  • CH du Pays d'Aix

    Aix en Provence,
    France

    Site Not Available

  • CHU Amien Picardie

    Amiens,
    France

    Site Not Available

  • Centre Hospitalier Universitaire d'Angers

    Angers,
    France

    Site Not Available

  • Centre Hospitalier d'Annecy

    Annecy,
    France

    Site Not Available

  • Centre Hospitalier Général de la Fontonne Antibes

    Antibes,
    France

    Site Not Available

  • CH de Bastia

    Bastia,
    France

    Site Not Available

  • Centre Hospitalier de Beauvais

    Beauvais,
    France

    Site Not Available

  • CHU Bordeaux Hôpital Haut Lévêque

    Bordeaux Pessac,
    France

    Site Not Available

  • Centre Hospitalier Universaitaire de Brest

    Brest,
    France

    Site Not Available

  • HIA Tonnerre

    Brest,
    France

    Site Not Available

  • Centre François Baclesse

    Caen,
    France

    Site Not Available

  • CH René Dubos - Pontoise

    Cergy Pontoise,
    France

    Site Not Available

  • Centre Hospitalier Charleville mézières

    Charleville Mézières,
    France

    Site Not Available

  • Centre Hospitalier Charleville mézières

    Charleville Mézières,
    France

    Site Not Available

  • CHI Créteil

    Créteil,
    France

    Site Not Available

  • CHI Créteil

    Créteil,
    France

    Site Not Available

  • Centre hospitalier de Draguignan

    Draguignan,
    France

    Site Not Available

  • Centre Hospitalier de Elbeuf

    Elbeuf,
    France

    Site Not Available

  • CH Gap

    Gap,
    France

    Site Not Available

  • CH La Roche sur Yon

    La Roche sur Yon,
    France

    Site Not Available

  • Hôpital A Mignot Le Chesnay

    Le Chesnay,
    France

    Site Not Available

  • Centre Omar Lambret

    Lille,
    France

    Site Not Available

  • Hôpital du Cluzeau

    Limoges,
    France

    Site Not Available

  • CHR Longjumeau

    Longjumeau,
    France

    Site Not Available

  • Centre Hospitalier de Bretagne Sud

    Lorient,
    France

    Site Not Available

  • Hôpital de la Croix Rousse

    Lyon,
    France

    Site Not Available

  • Centre Hospitalier

    Mantes La Jolie,
    France

    Site Not Available

  • Hôpital Sainte Marguerite

    Marseille,
    France

    Site Not Available

  • Institut Paoli-Calmette

    Marseille,
    France

    Site Not Available

  • Centre Hospitalier

    Martigues,
    France

    Site Not Available

  • Hôpital Saint Farron

    Meaux,
    France

    Site Not Available

  • Centre Hospitalier de Mulhouse

    Mulhouse,
    France

    Site Not Available

  • CHR Orléans

    Orléans,
    France

    Site Not Available

  • CHR Orléans

    Orléans,
    France

    Site Not Available

  • Paris Hôpital saint Antoine

    Paris,
    France

    Site Not Available

  • Centre Catalan

    Perpignan,
    France

    Site Not Available

  • Centre Hospitalier de Périgueux

    Périgueux,
    France

    Site Not Available

  • Centre Hospitalier de Périgueux

    Périgueux,
    France

    Site Not Available

  • Rennes Hospital University

    Rennes, 35033
    France

    Site Not Available

  • CHU Rouen Hôpital Boisguillaume

    Rouen,
    France

    Site Not Available

  • Hôpital Charles Nicolle

    Rouen,
    France

    Site Not Available

  • CHU Saint Etienne - Hôpital Nord

    Saint Etienne,
    France

    Site Not Available

  • Centre Hospitalier Général Salon de Provence

    Salon de Provence,
    France

    Site Not Available

  • Institut de Cancérologie de la Loire

    St Priest en Jarez,
    France

    Site Not Available

  • Hôpital Font-Pre

    Toulon,
    France

    Site Not Available

  • Hôpital d'Instruction des Armées

    Toulon Naval,
    France

    Site Not Available

  • CHU Touloues

    Toulouse,
    France

    Site Not Available

  • Centre Hospitalier De Villefranche sur Saone

    Villefranche sur Saone,
    France

    Site Not Available

  • Hôpital Yves Le Foll

    saint Brieuc,
    France

    Site Not Available

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